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HAT Trial

HAT Trial. Results of the Home Automated External Defibrillator Trial (HAT). HAT Trial. HAT Trial. Presented at ACC 2008 in Chicago Presented by Dr. Gust H. Bardy. Copyleft Clinical Trial Results. You Must Redistribute Slides. HAT Trial: Background.

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HAT Trial

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  1. HAT Trial Results of the Home Automated External Defibrillator Trial (HAT)

  2. HAT Trial HAT Trial Presented at ACC 2008 in Chicago Presented by Dr. Gust H. Bardy Copyleft Clinical Trial Results. You Must Redistribute Slides

  3. HAT Trial: Background • The majority of sudden cardiac arrests (SCA) occur at home • Home automated external defibrillators (AED) can minimize the time between symptom onset and treatment by EMS • The goal of HAT was to evaluate the efficacy of home AEDs on the survival of patients moderately at risk for SCA and not in need of implantable cardioverter defibrillator (ICD) therapy N Engl J Med 2008; 358/ACC 2008

  4. HAT Trial: Study Design 7,001 patients with previous anterior-wall MI for whom an implantable cardioverter-defibrillator was not necessary. Prospective. Randomized. Median follow-up of 37 months R AED Therapy AED use, EMS call, CPR by companion n=3495 Control Therapy EMS call, CPR by companion n=3506 20.4-55.6mos. follow-up • Primary Endpoint: all-cause mortality • Secondary Endpoints: survival from sudden cardiac arrest, quality of life Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008; 358/ACC 2008

  5. HAT Trial: Patient Characteristics *AED denotes automated external defibrillator **Race or ethnic group was self-reported Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008; 358/ACC 2008

  6. HAT Trial: Patient Characteristics *MI denotes myocardial infarction **Percentages are based on 2987 patients in the control group and 2967 in the AED group Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008; 358/ACC 2008

  7. HAT Trial: Patient Characteristics Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  8. HAT Trial: Patient Characteristics *EF denotes ejection fraction Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  9. HAT Trial: Patient Characteristics Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  10. HAT Trial: Patient Characteristics *The body-mass index is the weight in kilograms divided by the square of the height in meters **Percentages are based on 3485 patients in the control group and 3477 in the AED group Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  11. HAT Trial: Patient Characteristics *NYHA denotes New York Heart Association Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  12. HAT Trial: Patient Characteristics *ACE denotes angiotensin-converting enzyme Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  13. HAT Trial: Spouse/Companion Characteristics Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  14. HAT Trial: Spouse/Companion Characteristics Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  15. HAT Trial: Primary Endpoint • There was no significant difference between the survival rates of the two groups. Mortality (%) p = 0.77 n = 3495 n = 3506 Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  16. HAT Trial: Primary Endpoint • At four years follow-up, there was no difference in the primary endpoint among the prespecified subgroups according to age (≥65 years vs. <65 years), sex, Q- vs. non-Q-wave MI, and nationality (U.S. vs. non-U.S.) • Treatment effect did differ significantly between diabetics and non-diabetics (p = 0.04) Mean Annual Mortality (%) n = 3506 n = 3495 Copyleft Clinical Trial Results. You Must Redistribute Slides New Engl J Med 2008; 358/ACC 2008

  17. HAT Trial: Primary Endpoint Outcomes Frequency of Events and HR , According to the Classified Mode of Death and Resuscitated Cardiac Arrest* Variable Control Group AED Group Hazard Ratio (n = 3506) (n = 3495) (95% CI)** *Percentages are based on the number of deaths. AED denotes automated external defibrillator, and CI confidence interval. **The hazard ratio is for the AED group as compared with the control group. Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008;358/ACC 2008

  18. HAT Trial: Cause of Death Outcomes Frequency of Events and HR , According to the Classified Mode of Death and Resuscitated Cardiac Arrest Variable Control Group AED Group Hazard Ratio (n = 3506) (n = 3495) (95% CI) Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008;358/ACC 2008

  19. HAT Trial: Cause of Death Outcomes Frequency of Events and HR , According to the Classified Mode of Death and Resuscitated Cardiac Arrest Variable Control Group AED Group Hazard Ratio (n = 3506) (n = 3495) (95% CI) Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008;358/ACC 2008

  20. HAT Trial: Death From Tachyarrhythmia Outcomes Frequency of Events and HR , According to the Classified Mode of Death and Resuscitated Cardiac Arrest Variable Control Group AED Group (n = 3506) (n = 3495) Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008;358/ACC 2008

  21. HAT Trial: Resuscitated Cardiac Arrest Outcomes Frequency of Events and HR , According to the Classified Mode of Death and Resuscitated Cardiac Arrest Variable Control Group AED Group (n = 3506) (n = 3495) Copyleft Clinical Trial Results. You Must Redistribute Slides N Engl J Med 2008;358/ACC 2008

  22. HAT Trial: Limitations Overall mortality and SCA incidence were much lower than predicted due to the efficacy and use of modern drug therapy and the high rate of previous revascularization (72.2%) in the patients Training patients and their companions to call EMS may not reflect real-world direction after MI New Engl J Med 2008; 358/ACC 2008

  23. HAT Trial: Limitations • This study only included low-risk patients • Future trials should consider the possible benefits of home access to AEDs among higher risk groups New Engl J Med 2008; 358/ACC 2008

  24. HAT Trial: Summary Patients who have survived anterior-wall MI and are not in need of a cardioverter-defibrillator do not benefit from using an AED at home prior to calling EMS. New Engl J Med 2008; 358/ACC 2008

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